Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024

Rhea-AI Summary

Astellas Pharma Inc. (TSE: 4503) will present eight abstracts at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, showcasing data from its oncology portfolio and pipeline. Key highlights include:

1. EV-302 study results on enfortumab vedotin with pembrolizumab for first-line treatment of urothelial cancer.

2. Five-year follow-up data from the EV-103 DE/A study on enfortumab vedotin with pembrolizumab in first-line cis-ineligible urothelial cancer.

3. Final pooled overall survival data from SPOTLIGHT and GLOW trials on zolbetuximab plus chemotherapy for gastric/GEJ adenocarcinoma.

4. EMBARK post-hoc analyses on enzalutamide for non-metastatic hormone-sensitive prostate cancer.

5. Phase 1 data on ASP3082, a KRAS G12D protein degrader, and ASP1570, a novel DGKζ inhibitor.

Positive

• Presentation of eight abstracts at ESMO 2024, including two oral presentations
• Five-year follow-up data from EV-103 DE/A study showing durable responses and meaningful survival in first-line urothelial cancer
• Final pooled overall survival data from SPOTLIGHT and GLOW trials for zolbetuximab in gastric/GEJ adenocarcinoma
• Phase 1 data from ASP3082, the first KRAS G12D protein degrader to enter clinical trials
• Preclinical and early clinical data from ASP1570, a novel DGKζ inhibitor, in advanced solid tumors

Negative

• None.

Medical Research Analyst

The data presented at ESMO 2024 highlights Astellas' progress in oncology, particularly in hard-to-treat cancers. Key findings include:

• EV-302 study shows enfortumab vedotin with pembrolizumab is effective in first-line treatment of locally advanced or metastatic urothelial cancer, regardless of Nectin-4 expression.
• Five-year follow-up of EV-103 DE/A study demonstrates durable responses and meaningful survival with the same combination in cisplatin-ineligible patients.
• SPOTLIGHT and GLOW trials reveal zolbetuximab plus chemotherapy improves overall survival in HER2-negative, Claudin 18.2-positive gastric or GEJ adenocarcinoma.
• EMBARK post-hoc analysis supports enzalutamide's benefits in high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer, both as monotherapy and combined with leuprolide.

These results demonstrate Astellas' commitment to advancing cancer treatment across multiple indications and patient subgroups.

Oncology Doctor

Astellas' presentations at ESMO 2024 showcase promising advancements in cancer treatment. The enfortumab vedotin-pembrolizumab combination in urothelial cancer is particularly noteworthy, showing efficacy regardless of Nectin-4 expression and long-term benefits in cisplatin-ineligible patients. This could potentially change the standard of care for these hard-to-treat patients.

The zolbetuximab data in gastric and GEJ adenocarcinoma is also significant, as it targets a specific biomarker (Claudin 18.2) and improves overall survival when combined with chemotherapy. This personalized approach could offer new hope for patients with treatment options.

Lastly, the enzalutamide results in prostate cancer and the early-phase data on novel compounds like ASP3082 (KRAS G12D degrader) and ASP1570 (DGKζ inhibitor) demonstrate Astellas' commitment to both improving existing therapies and developing innovative approaches to cancer treatment.

Financial Analyst

Astellas' strong presence at ESMO 2024 with eight abstracts across multiple cancer types demonstrates the company's robust oncology pipeline and potential for future revenue growth. Key points for investors:

• The positive data on enfortumab vedotin could lead to expanded market share in urothelial cancer, a $1-2 billion market opportunity.
• Zolbetuximab's efficacy in gastric and GEJ cancers opens up a new market segment, potentially adding $500 million to $1 billion in peak sales.
• Continued success of enzalutamide in prostate cancer helps maintain Astellas' strong position in this $10+ billion market.
• Early-stage assets like ASP3082 and ASP1570 show promise in addressing unmet needs, potentially leading to first-in-class therapies with significant market potential.

These developments position Astellas well for sustained growth in the competitive oncology market, potentially driving stock appreciation in the medium to long term.

- Eight abstracts, including two oral presentations, feature new clinical data from Astellas' oncology portfolio and two lead pipeline programs across a broad range of cancer types -

TOKYO, Sept. 11, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society for Medical Oncology (ESMO) Congress being held in Barcelona, Spain on 13-17 September. Eight abstracts across a broad range of cancer types will be presented, reinforcing Astellas' commitment to making a meaningful difference to people living with advanced and hard-to-treat cancers. Six abstracts include data spanning prostate, urothelial, gastric and gastroesophageal junction (GEJ), and pancreatic cancers. Two abstracts feature Phase 1 data presented for the first time from immuno-oncology and targeted protein degradation assets.

Tadaaki Taniguchi, MD, PhD, Chief Medical Officer, Astellas:
"The data presented at ESMO are an exciting demonstration of the strength of our portfolio and the transformative potential of our pipeline to help deliver outcomes that matter for patients. Astellas has made a long-term commitment to helping people living with hard-to-treat cancers by both investing in next-generation modalities like targeted protein degradation and immuno-oncology, and by maximizing the number of patients that could benefit from our approved medicines."

Highlights at the ESMO Congress 2024 include:

• Data from the Phase 3 EV-302 study, evaluating Nectin-4 expression and response to first-line treatment of enfortumab vedotin in combination with pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). These results support the combination as a first-line advancement across la/mUC patient subgroups, regardless of Nectin-4 expression.
• Five-year follow-up data from the Phase 1/2b EV-103 DE/A study, analyzing durable responses and meaningful survival to enfortumab vedotin in combination with pembrolizumab in patients with first-line cis-ineligible la/mUC. These results further support the broad suitability, regardless of cis-eligibility, and long-term benefits of this regimen in la/mUC.
• Final pooled overall survival data from the Phase 3 SPOTLIGHT and GLOW trials, evaluating zolbetuximab plus chemotherapy as a first-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumors are Claudin 18.2-positive.
• Updates involving a Phase 2 trial in progress assessing zolbetuximab in combination with gemcitabine and nab-paclitaxel (GN) versus GN monotherapy as first-line treatment of Claudin 18.2-positive metastatic pancreatic cancer.
• Phase 3 EMBARK post-hoc analyses, evaluating enzalutamide in combination with leuprolide and as monotherapy versus leuprolide alone in patients with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer. These results support the benefits of enzalutamide both in combination with leuprolide and as monotherapy in patients aged <70 and ≥70 years.  
• Clinical data from lead pipeline assets: Phase 1 data from ASP3082, the first protein degrader targeting KRAS G12D mutant to enter clinical trials, in patients with advanced pancreatic, colorectal, and non-small cell lung cancer; and preclinical, translational/early clinical data from ASP1570, a novel DGKζ inhibitor, in patients with advanced solid tumors. The results support continued study of these investigational therapies for the treatment of various cancer types.

 

Astellas Presentations at 2024 ESMO Congress

Enfortumab vedotin

Presentation title	Speaker	Presentation details
EV-302: Exploratory Analysis of Nectin-4 Expression and Response to 1L Enfortumab Vedotin (EV) + Pembrolizumab (P) in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer (la/mUC)	T. Powles	Type: Mini Oral Session  Abstract Number: 1966MO Date: September 15
Study EV-103 Dose Escalation/Cohort A (DE/A): 5y Follow-Up Of First-Line (1L) Enfortumab Vedotin (EV) + Pembrolizumab (P) in Cisplatin (cis)-Ineligible Locally Advanced Or Metastatic Urothelial Carcinoma (la/mUC)	J. Rosenberg	Type: Poster Abstract Number: 1968P Date: September 15
Epidemiology and treatment patterns of patients with locally advanced or metastatic urothelial cancer in France: a non-interventional database study	F. Joly	Type: Poster Abstract Number: 2001P Date: September 15

 

Zolbetuximab

Presentation title	Speaker	Presentation details
First-line (1L) zolbetuximab + chemotherapy in patients (pts) with claudin 18.2 (CLDN18.2) +, HER2–, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: A pooled final analysis of SPOTLIGHT + GLOW	Y-K Kang	Type: Poster Abstract Number: 1438P Date: September 16
Zolbetuximab With Gemcitabine + Nab-Paclitaxel (GN) in First-Line Treatment of Claudin 18.2–Positive Metastatic Pancreatic Cancer (mPC): Phase 2, Open-Label, Randomized Study	W. Park	Type: Poster Abstract Number: 1532TiP Date: September 16

 

Enzalutamide

Presentation title	Speaker	Presentation details
Enzalutamide (enza) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post-hoc analysis by age	N. D. Shore	Type: Poster  Abstract Number: 1638P Date: September 15

 

Pipeline

Presentation title	Speaker	Presentation details
Phase 1/2 Trial of ASP1570, a Novel Diacylglycerol Kinase ζ Inhibitor, in Patients With Advanced Solid Tumors	D. Olsen	Type: Poster  Abstract Number: 1004P Date: September 14
Preliminary safety and clinical activity of ASP3082, a first-in-class, KRAS G12D selective protein degrader in adults with advanced pancreatic (PC), colorectal (CRC), and non-small cell lung cancer (NSCLC)	W. Park	Type: Proffered Paper Session  Abstract Number: 608O Date: September 15

 

About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+^® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.

About PADCEV and the Astellas, Pfizer and Merck Collaboration
Astellas and Pfizer have a clinical collaboration agreement with Merck to evaluate the combination of Astellas' and Pfizer's PADCEV™ (enfortumab vedotin-ejfv) and Merck's KEYTRUDA^® (pembrolizumab) in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada).

About XTANDI and the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE:4503) entered into a commercial agreement to jointly develop and commercialize XTANDI^® (enzalutamide) in the United States, while Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the product outside the United States. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S.

Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

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SOURCE Astellas Pharma Inc.

FAQ

What are the key studies Astellas is presenting at ESMO 2024 for urothelial cancer?

Astellas is presenting results from the EV-302 study on enfortumab vedotin with pembrolizumab for first-line treatment of urothelial cancer, and five-year follow-up data from the EV-103 DE/A study on the same combination in first-line cis-ineligible urothelial cancer.

What data is Astellas presenting on zolbetuximab at ESMO 2024?

Astellas is presenting final pooled overall survival data from the SPOTLIGHT and GLOW trials on zolbetuximab plus chemotherapy for first-line treatment of HER2-negative, Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma.

What pipeline assets is Astellas presenting data on at ESMO 2024?

Astellas is presenting Phase 1 data on ASP3082, a KRAS G12D protein degrader for advanced pancreatic, colorectal, and non-small cell lung cancer, and preclinical and early clinical data on ASP1570, a novel DGKζ inhibitor for advanced solid tumors.

What prostate cancer data is Astellas presenting at ESMO 2024?

Astellas is presenting EMBARK post-hoc analyses on enzalutamide, both in combination with leuprolide and as monotherapy, for patients with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer.